New blood sugar monitor put to the test in type 1 diabetes trial
NCT ID NCT07296276
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing how well a new continuous glucose monitor, called CareSens Air 3, measures blood sugar levels in adults with type 1 diabetes. Researchers will compare the monitor's readings to standard lab measurements. The goal is to see if the device is accurate and precise enough for everyday use.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CareSens Air 3 continuous glucose monitoring system
- What this could lead to
- If successful, this could provide a more accurate and reliable way for people with type 1 diabetes to monitor their blood sugar levels.
- What could go wrong
- This is a small, early pilot study with only 32 participants, so results may not apply to everyone. The device may not be as accurate as hoped.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 32 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Apr 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Adults who are 18-65 years of age, inclusive * Patients with type 1 diabetes who use intensive insulin therapy (multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII) including users of systems with continuous glucose monitoring (CGM) driven automatic adjustment of insulin doses for at least 3 months * Patients who voluntarily decide to participate in the study and provide written informed consent Exclusion Criteria: * The following abnormal skin or skin diseases or skin alterations at the CGM sensor attachment or insertion site: Severe psoriasis, recent burn injury or severe sunburn, severe eczema, severe scar, extensive tattoo, dermatitis herpetiformis, severe rash, Staphylococcus aureus infection. * Allergic contact dermatitis to medical adhesives. * History of frequent catheter abscesses associated with pump therapy. * Severe hypoglycemia events within 3 months prior to screening. Severe hypoglycemia is defined as loss of consciousness or seizure requiring emergency medical treatment due to hypoglycemia. * Hypoglycemia unawareness. * Conditions that predispose to hypoglycemia including inadequately treated thyroid and adrenal disease. * Participants with diabetic ketoacidosis within 3 months prior to screening. * History of epilepsy or syncope within 6 months prior to screening. * Unstable vascular diseases (defined by event or increasing symptoms in the last 6 months) or with insufficient therapy, including: Stroke, transitory cerebral ischemia, ischemic heart disease, peripheral vascular disease, and serious arrhythmia. * Patients with anemia (hemoglobin below normal range). * Patients scheduled for X-ray, MRI, CT or diathermy during the study. * Pregnant or lactating women or those who plan to become pregnant or do not agree to use an adequate method of contraception during the study. * Patients who are currently participating or participated within 2 weeks prior to screening in another study or plan to participate in another study that in the opinion of the investigator would affect the safety of the study participant or the study result. * Patients unwilling to abstain from ingesting the foodstuffs listed in Appendix 3 in excess of the allowed amounts. * Patients with cognitive impairment or who are not suitable for this study or may be at increased risk associated with study participation in the opinion of the investigator. * Wearing of a pace maker or other comparable medical devices. * HbA1c \>9.5%. * Dependency from the sponsor or the clinical investigator. * Unwillingness and/or inability to comply with study procedures.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Atlanta Diabetes Associates
NOT_YET_RECRUITINGAtlanta, Georgia, 30318, United States
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Diablo Clinical Research
RECRUITINGWalnut Creek, California, 94598, United States
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Headlands Research AMCR
NOT_YET_RECRUITINGEscondido, California, 92025, United States
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Rainier Clinical Reseach Center
RECRUITINGRenton, Washington, 98057, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Gene therapy aims to free type 1 diabetics from insulin shots
- Muscle-Injected gene therapy aims to help type 1 diabetes control blood sugar
- Can a glucose sensor and family coaching tame type 1 diabetes in toddlers?
- Can a smartphone app help heal diabetic foot wounds?
- Can a handoff plan help teens with chronic illness take charge of their care?
- Cheap blood test could flag diabetic kidney damage before it strikes